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First Wave BioPharma(FWBI) - 2023 Q3 - Quarterly Report

Financial Performance - For the three months ended September 30, 2023, the company reported net loss of approximately $3.4 million, an increase of approximately $7.8 million, or 157%, compared to a net income of approximately $4.4 million for the same period in 2022[180]. - Net loss for the nine months ended September 30, 2023 was approximately $11.7 million, an increase of approximately $1.1 million, or 10%, compared to $10.6 million for the same period in 2022[191]. - Net cash used in operating activities for the nine months ended September 30, 2023 was approximately $8.4 million, a decrease from $16.8 million used in the same period in 2022[192]. - Net cash provided by financing activities for the nine months ended September 30, 2023 was approximately $10.9 million, compared to $10.2 million for the same period in 2022[196][197]. Research and Development Expenses - Research and development expenses for the three months ended September 30, 2023 totaled approximately $1.0 million, an increase of approximately $0.2 million, or 28%, over the approximately $0.8 million for the same period in 2022[172]. - Research and development expenses for the nine months ended September 30, 2023 totaled approximately $3.7 million, a decrease of approximately $4.9 million, or 57%, compared to $8.7 million for the same period in 2022[183]. - The company expects research and development expenses to decrease as it closes out the Phase 2b Adrulipase SPAN clinical trial[175]. - The company expects research and development expenses to decrease during the remainder of the fiscal year as it works to close out the Phase 2b Adrulipase SPAN clinical trial[186]. General and Administrative Expenses - General and administrative expenses for the three months ended September 30, 2023 totaled approximately $2.4 million, a decrease of approximately $0.5 million, or 17%, compared to approximately $2.9 million for the same period in 2022[177]. - General and administrative expenses for the nine months ended September 30, 2023 totaled approximately $8.0 million, a decrease of approximately $1.9 million, or 19%, compared to $9.8 million for the same period in 2022[188]. - The company anticipates general and administrative expenses to remain stable during the remainder of the fiscal year[178]. - General and administrative expenses are expected to remain stable during the remainder of the fiscal year[189]. Cash Position and Equity - As of September 30, 2023, the company had cash and cash equivalents of approximately $3.3 million and cumulative losses attributable to common stockholders of approximately $180.2 million[164]. - The company reported stockholders' equity of $881,960 as of June 30, 2023, which is below the $2.5 million minimum requirement for continued listing on Nasdaq[160]. Future Plans and Assessments - The company plans to initiate a Phase 2 clinical development program for Capeserod in either pediatric ulcerative colitis or gastroparesis[156]. - The company is continuing to assess data from the Phase 2b monotherapy bridging study of Adrulipase and plans to schedule a Type C meeting with the FDA in 2024[155]. - The company is dependent on obtaining additional funding to continue operations and may not achieve profitability in the foreseeable future[164]. Clinical Trial Expenses - The company recorded a decrease in clinical-related expenses of approximately $3.7 million for the Phase 2b Adrulipase SPAN clinical trial compared to the previous year's Phase 2 RESERVOIR COVID-19 GI clinical trial[183]. - Other expenses for the nine months ended September 30, 2023 decreased approximately $0.2 million, or 93%, compared to the same period in 2022[190]. - Research and development recovery related to intellectual property acquired was $0 million for the nine months ended September 30, 2023, compared to $8.1 million for the same period in 2022[185].